Lead Cell Culture Process Scientist (Pivotal)

Biopharma Careers; Foster City (CA); On-site; USD 169,000 - 219,000; Full time

Job summary

Gilead Sciences Inc. is seeking a Senior Scientist, Cell Culture Process Development, to lead pivotal and commercial cell culture development across biologics programs.

You will drive process characterization, tech transfer coordination, and regulatory documentation while mentoring a growing team in a fast-paced environment. The role involves hands-on operations, experimental design, and collaboration with MSAT and manufacturing groups to enable robust, scalable processes for BLA submissions and

Qualifications

• Bachelor's Degree with 8+ years of experience, or Master's with 6+ years, or PhD/PharmD.
• Experience leading pivotal stage cell culture process development and GMP facilities.
• Strong communication, writing, and cross-functional collaboration.

Responsibilities

• Optimize and characterize cell culture processes for pivotal trials and commercialization.
• Lead process characterization, PPQ, and BLA documentation.
• Support technology transfer with MSAT group.
• Design experiments and perform hands-on cell culture operations.
• Support pilot plant operations up to 500 L single-use bioreactor.
• Perform statistical analysis and modeling of process parameters.
• Prepare GMP/non-GMP technical documents and present findings.
• Mentor and develop junior team members; travel for technology transfers.

Skills

Cell culture

Process development

Regulatory documentation

Biologics

Education

Bachelor's degree

Master's degree

PhD/PharmD

Job description

Gilead Sciences Inc. is seeking a Senior Scientist, Cell Culture Process Development, to lead pivotal and commercial cell culture development across biologics programs.

You will drive process characterization, tech transfer coordination, and regulatory documentation while mentoring a growing team in a fast-paced environment. The role involves hands-on operations, experimental design, and collaboration with MSAT and manufacturing groups to enable robust, scalable processes for BLA submissions and